Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

March 4, 2015 updated by: Bausch & Lomb Incorporated
The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16501
        • Pediatric Ophthalmology of Erie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children 0-6 years of age.
  • clinical diagnosis of blepharoconjunctivitis
  • Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
  • Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

  • Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
  • Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
  • Subjects who are monocular.
  • Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
  • Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Loteprednol etabonate and tobramycin
Drug: Zylet (loteprednol etabonate and tobramycin)
Drug: loteprednol etabonate and tobramycin
Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
Other Names:
  • Zylet
Active Comparator: Loteprednol etabonate
Drug: Lotemax (loteprednol etabonate)
Drug: loteprednol etabonate
Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
Other Names:
  • Lotemax
Active Comparator: Tobramycin
Drug: Tobramycin
Drug: Tobramycin
Topical ocular administration of Tobramycin QID for 14 days.
Placebo Comparator: Vehicle
Vehicle of Zylet
Drug: Vehicle of Zylet
Topical ocular administration of the vehicle of Zylet QID for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Total Blepharoconjunctivitis Grade.
Time Frame: Baseline to 15 days
Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Baseline to 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
Time Frame: Baseline to Day 3
Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Baseline to Day 3
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3
Time Frame: Baseline to Day 7
Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Baseline to Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

June 20, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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